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U.S. Department of Health and Human Services

Class 2 Device Recall RadiForce GX560

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  Class 2 Device Recall RadiForce GX560 see related information
Date Initiated by Firm July 30, 2019
Create Date June 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-2293-2020
Recall Event ID 85299
510(K)Number K181609  
Product Classification Display, diagnostic radiology - Product Code PGY
Product RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Code Information RadiForce GX560 - 1.0003 or earlier
Recalling Firm/
Manufacturer		 Eizo Corporation
Eizo ( Kabu )
Hakusan Japan
For Additional Information Contact Mr. Martin Ruiz
562-431-5011 Ext. 154
Manufacturer Reason
for Recall		 Under certain conditions, a marble pattern infrequently appears on the monitor.
FDA Determined
Cause 2		 Device Design
Action EIZO Japan announced the recall on their website on 7/30/2019. EIZO U.S. began contacting their consignees via email and phone (one as early as 8/7/2019, some on 10/18/2019, but the majority on 11/26/2019) and began updating consignee monitors with the firmware. The notification requested the consignee contact EIZO U.S. for assistance with the firmware update.
Quantity in Commerce 96 monitors dist. to the U.S.
Distribution Worldwide distribution - US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin. Distribution was also made to Puerto Rico. There was no government/military consignees. The countries of Canada, Australia, Austria, Belgium, Brazil, China, Czech Republic, Egypt, France, Germany Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Pakistan, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PGY and Original Applicant = EIZO Corporation
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